Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2026-01-01 @ 2:33 AM
Study NCT ID:
NCT05246969
Status:
COMPLETED
Last Update Posted:
2022-03-29
First Post:
2022-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detecting Sepsis in Patients With Severe Subarachnoideal Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-14', 'studyFirstSubmitDate': '2022-02-09', 'studyFirstSubmitQcDate': '2022-02-17', 'lastUpdatePostDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sepsis SOFA positive', 'timeFrame': 'up to 2 months', 'description': 'Sepsis correctly detected by SOFA score (Sepsis-related organ failure assessment score, 0-24 points)'}, {'measure': 'Sepsis SOFA negative', 'timeFrame': 'up to 2 months', 'description': 'Sepsis not detected by SOFA score (Sepsis-related organ failure assessment score, 0-24 points)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sequential organ failure assessment score'], 'conditions': ['Subarachnoid Hemorrhage', 'Subarachnoid Hemorrhage, Aneurysmal', 'Sepsis Syndrome', 'Sepsis', 'Sepsis, Severe', 'Sepsis Bacterial']}, 'descriptionModule': {'briefSummary': 'The study aims to evaluate the suitability of the SOFA score implemented by the Sepsis 3 guideline to detect sepsis in patients suffering from subrarachnoid hemorrhage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with severe subarachnoid hemorrhage requiring intensive care.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCritically ill patients suffering from moderate to severe subarachnoid hemorrhage (WFNS \\>2).\n\nExclusion Criteria:\n\nchildren under the age of 18 years Patients with minor subarachnoid hemorrhage \\< WFNS stage 2.'}, 'identificationModule': {'nctId': 'NCT05246969', 'briefTitle': 'Detecting Sepsis in Patients With Severe Subarachnoideal Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Goethe University'}, 'officialTitle': 'Detecting Sepsis in Patients With Severe Subarachnoideal Hemorrhage', 'orgStudyIdInfo': {'id': 'Sepsis in SAH'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Sepsis detection', 'type': 'OTHER', 'description': 'The aim of the study was to observe whether the treating physicians were able to detect sepsis by strictly applying the recommended SOFA score.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60590', 'city': 'Niederrad', 'state': 'Hesse', 'country': 'Germany', 'facility': 'University Hospital Frankfurt', 'geoPoint': {'lat': 50.08309, 'lon': 8.62852}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The dataset will be published in an international journal. The data will be available upon reasonable request from the corresponding author'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Goethe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Armin N. Flinspach', 'investigatorAffiliation': 'Goethe University'}}}}